PVA-based formulations as a design-technology platform for orally disintegrating film matrices

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Drug Delivery

Background:

• Polymers are crucial in pharmaceutical applications, especially for solid oral dosage forms.
• Orally disintegrating films (ODFs) offer an alternative for patients with swallowing difficulties.
• Understanding polymer properties and characterization is key for novel drug delivery systems.

Purpose of the Study:

• To investigate how different formulation approaches affect the properties of polyvinyl alcohol (PVA) based films.
• To optimize the disintegration time and drug release profile of poorly water-soluble haloperidol (HAL).
• To establish correlations between manufacturing techniques, film characteristics, and drug dissolution behavior.

Main Methods:

• Formulation approaches included solvent casting (SC), 3D printing (3DP), electrospinning (ES), and lyophilization (LP).
• Lactic acid was added to enhance haloperidol solubility.
• Film characterization involved morphology (SEM, micro-CT), physicochemical properties, thermal analysis (TMDSC, TGA), and structural analysis (PXRD).

Main Results:

• The four preparation techniques (SC, 3DP, ES, LP) successfully modified haloperidol release from PVA films.
• Morphological, thermal, and structural analyses provided insights into film properties.
• Correlations were established between preparation technology, film structure, and drug release.

Conclusions:

• Manufacturing technique significantly influences the properties and drug release of PVA-based ODFs.
• The study demonstrates the adaptability of ODF manufacturing for controlling drug dissolution.
• These findings aid in selecting appropriate techniques for developing effective ODFs for poorly soluble drugs.